Health Ministry Bans Chlorpheniramine Phenylephrine Combo for Children Below 4, Mandates Warning Labels

This FDC is a common formulation found in numerous over-the-counter cold and allergy medications, especially pediatric syrups. The new directive mandates that pharmaceutical manufacturers must now update packaging and marketing materials to include the prescribed warning. Failure to comply could lead to regulatory action, including prohibition of sale.

The decision, published in the Gazette of India on April 15, follows detailed evaluations by two expert panels, the Subject Expert Committee and the Drugs Technical Advisory Board (DTAB), which both concluded that the combination poses risks to young children and should carry mandatory warning labels.

Expert Panels Raise Red Flags

According to the government notification,

“The Central Government is satisfied that the use of the drug fixed dose combination of Chlorpheniramine Maleate + Phenylephrine Hydrochloride is likely to involve risk to children below four years of age and whereas safer alternatives to the said drug are available.”

This conclusion was reached after the Subject Expert Committee, appointed by the Centre, recommended against the use of this combination in children below four years. It advised that all manufacturers must include a warning on the label, package insert, or promotional literature stating: “Fixed dose combination shall not be used in children below four years of age.”

Drugs Technical Advisory Board Backs Ban for Young Children

Reinforcing the stance, the DTAB also examined the matter and made a similar recommendation, calling for a regulatory restriction under Section 26A of the Drugs and Cosmetics Act, 1940. The board not only endorsed the ban for use in the under-four age group but also stated that the FDC should not be manufactured, sold, or distributed for this demographic unless the label carries the specified cautionary statement.

Central Government Imposes Nationwide Restriction

Acting on these expert recommendations, the government has issued a formal directive under Section 26A;

“The Central Government hereby restricts the manufacture, sale or distribution of all formulations of fixed dose combination of Chlorpheniramine Maleate + Phenylephrine Hydrochloride subject to the following condition, that the manufacturers shall mention the warning ‘fixed dose combination shall not be used in children below four years of age’ on the label and package insert or the promotional literature of the drug.”

The restriction takes immediate effect from the date of publication in the official Gazette, i.e., April 15, 2025.

The notification has been issued under file number X.11035/132/2024-DR, signed by Rajiv Wadhawan, Adviser (Cost), Ministry of Health and Family Welfare.

As the implementation rolls out, both manufacturers and healthcare providers will need to realign their practices to ensure that no formulation of this drug is administered to children under four, thus reinforcing public safety in pediatric medication use.